What do built-in Softwares in Home Ventilators Tell us?
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|ClinicalTrials.gov Identifier: NCT01159444|
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : July 9, 2010
|Condition or disease|
Observational study of patients under home positive pressure mechanical ventilation, in a stable condition.
Data recorded by ventilator software is downloaded by specialized nurses during elective home visits, as well as spirometry, results of recent pulse oximetry, ventilator settings, diagnosis, and basic anthropometric data.
Items recorded by ventilator software are: tidal volume, total ventilation, apnea and hypopnea index, leaks, percentage of inspiratory cycles triggered by ventilator, spontaneous and back-up respiratory rates.
Results are reported by diagnostic group. Statistical analysis (univariate and multivariate) aims to determine which variables are related to unintentional leaks, and whether ventilator settings differ significantly between diagnostic groups.
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||What do built-in Softwares in Home Ventilators Tell us? An Observational Study of 150 Patients on Home Ventilation|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||July 2010|
- Analysis of data downloaded from ventilator software by diagnostic category [ Time Frame: one day ]Analysis of data provided by ventilator software during elective home visits by specialized nurses in stable patients under home ventilation. Data includes all ventilator parameters, leaks, tidal volume, total ventilation, respiratory rate, % of cycles triggered by the patient, apnea-hypopnea index, and compliance. Age, gender, BMI, spirometry, type of mask and pulse oximetry are also available. The analysis will describe ventilatory patterns and ventilator settings as a function of diagnosis, as well as factors related to importance of leaks (age, interface, ventilator settings).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159444
|Division of Pulmonary Diseases; Geneva University Hospital|
|Geneva 14, Geneva, Switzerland, 1211|
|Principal Investigator:||Jean-Paul Janssens, Professor||Division of Pulmonary Diseases; Geneva University Hospital|